Original Title: Evaluación de la evidencia científica sobre la micropigmentación del complejo areola-pezón, requisitos para su adecuada realización y costes

Authors' objectives: The general objectives of this project were to evaluate the scientific evidence on NAC micropigmentation regarding safety, costs and patient satisfaction, as well as to assess patient opinions, the relevant legislation and whether this technique is available in public hospitals for breast cancer patients who have undergone mastectomy

Authors' results and conclusions: • The literature search yielded 15 scientific articles that provided data on the safety of micropigmentation and patient satisfaction with the technique, but none assessing the costs of the procedure. The data found indicated that NAC micropigmentation is a safe technique (only 2.3 % of women included in the papers reviewed reporting mild adverse effects) and is associated with a high level of satisfaction (women being highly satisfied with the general appearance of the reconstruction in 91 % of cases, with the position in 91 %, with the dimension/size in 90 %, and with the colour of the areola and nipple respectively in 76 % and 79 %). Further, 94 % of the women reported that it had had a positive impact on their lives. • Representatives of seven autonomous regions, Andalusia, the Balearic Islands, Castilla-La Mancha, Castilla y León, Catalonia, Madrid and Murcia, stated that NAC micropigmentation is currently offered in public hospitals in their region. They provided information on the number of procedures carried out in the previous 3 years, the healthcare professionals that performed them and place where they were performed within the hospital, how they were performed and the estimated number of women who were offered and agreed to receive micropigmentation. • The per-session costs were €134 and €155 for unilateral and bilateral 3D NAC micropigmentation carried out by nurses in the plastic surgery department (10.9 % and 15.5 % higher, respectively, if performed by a plastic surgeon), €78 and €91 for the unilateral and bilateral simple procedure (18.9 % and 21.8 % higher, respectively, if performed by a plastic surgeon) and €85 for touching up the NAC micropigmentation (10.4 % higher if carried out by a plastic surgeon). The cost of carrying out further micropigmentation, due to fading of the colour over time, was the same as the aforementioned costs for the initial procedures, for both nurses and plastic surgeons. • The economic costs of providing NAC micropigmentation by nurses in plastic surgery consultations to all women who might request were estimated to be: €707,383 for 2017, €709,750 for 2018, €720,179 for 2019 and €1,299,334 for 2020, for scenario 1; and €691,433 for 2017, €693,694 for 2018, €703,835 for 2019 and €1,269,755 for 2020, for scenario 2. If the initial micropigmentation procedures, touch-ups and further micropigmentation treatment due to fading were to be carried out by a plastic surgeon, the costs would be 11 % higher per year than the aforementioned values. • Two focus groups were held with a total of 9 women who expressed their opinions concerning NAC micropigmentation. Participants in the first focus group were seven members of two associations for women who have or have had breast cancer: the Bilbao Association for Breast Cancer (ACAMBI, based in the province of Bizkaia) and the Gipuzkoan Association supporting Women affected by Breast or Gynaecological Cancer (KATXALIN, based in the province of Gipuzkoa). The second focus group was held with two representatives of the Araba Association for Women with Breast or Gynaecological Cancer (ASAMMA, based in the province of Araba). Most of the participants claimed to be satisfied with procedure and all requested that the technique be publicly funded in all regions across Spain, to achieve equality in access to resources and treatments after breast cancer. They also thought that further pigmentation procedures should be funded, since it is common that the colour achieved by NAC micropigmentation changes or fades over time. • All 17 Spanish regions have passed legislation setting healthcare standards that should be met by all centres carrying out tattooing, micropigmentation and/or piercing, as well as how to establish the basic hygiene and sanitary measures that should be taken by professionals performing these procedures. Additionally, special importance is given to the need for prior training for these professionals and the minimum necessary length of training, this being 15 hours in the regions of Aragón, Balearic Islands and Valencia and 40 hours in the Basque Country, Madrid, La Rioja and Andalusia. CONCLUSIONS Safety of the technique. According to the data analysed, NAC micropigmentation is a safe and simple technique, requires neither general anaesthesia nor hospitalization, and can be performed in nursing clinics under local anaesthesia by nurses with specific training. Economic implications. The economic analysis indicates that the total cost per session whether unilateral or bilateral, of 3D and simple nipple-areola micropigmentation, touch-up treatment and further micropigmentation (due to fading of the previous treatment) depends on staff costs, the time required, the number and cost of the pigments employed, and the cost of needles used. The analysis estimating the economic implications for the Spanish Health Service of providing NAC micropigmentation to all women requesting it, for the period 2017-2020 under the two scenarios studied, indicates that it depends on the costs of the technique used, the number of women that request touch-up treatment and the need for further micropigmentation sessions due to fading. Regarding the training required to ensure that professionals carry out the technique effectively and safely, this should be involve practice as well as theory. Women’s satisfaction. According to studies assessing satisfaction, women are highly satisfied with the general appearance of the reconstruction, position, and dimension/size of the NAC, though slightly less satisfied with the colour of the nipple and/or areola. For most patients, NAC micropigmentation has a positive impact on their lives. In the focus groups, the majority of participants were highly satisfied with the outcomes of the micropigmentation and thought that treatment should be ongoing due to the need for further micropigmentation. Implications for clinical practice. Given the differences observed between the responses given by the seven Spanish regions in which public hospitals offer this procedure, and the variability between the regions in the relevant legislation, we suggest a protocol be established for all public hospitals in the health service network to ensure that the NAC micropigmentation technique is implemented in a homogeneous way across the network. Future lines of research. There are numerous areas for future work including analysis of how NAC micropigmentation is implemented; medium/long term follow-up of the safety of the technique and different approaches; validation and implementation of a questionnaire to assess satisfaction among women who undergo NAC micropigmentation; creation, validation and implementation of a questionnaire to assess the impact of this treatment on women’s quality of life; and the involvement of patients in the drafting of new patient information leaflets on this procedure. Additionally, all Spanish regions should adopt common legislation on healthcare standards for performing NAC micropigmentation.

Authors' methods: • To evaluate the scientific evidence on safety, costs and patient satisfaction, we performed a systematic review, starting with a structured search in databases specialized in systematic reviews, general medical databases and databases dedicated to economic analysis. • To determine the level of use of this technique across the Spanish regions, National Institute of Health Management (INGESA), and health insurance plans for civil servants (ISFAS, MUGEJU and MUFACE), we sought to determine which public hospitals of the Spanish National Health Service and private centres supported by public funds carry out the NAC micropigmentation technique through a survey among representatives of the health system’s Services, Insurance and Financing Committee. • To assess the costs of the NAC micropigmentation technique, we carried out an economic analysis of the procedure. From the point of view of the Spanish National Health Service funding body, and for a time horizon of 1 year, we calculated the direct healthcare costs per session for the following: 3D nipple-areola micropigmentation, simple nipple-areola micropigmentation, touch-up treatment and further micropigmentation due to fading of the previous micropigmentation. In addition, we estimated what it would cost the health service to provide micropigmentation to all women who might request it for a period of 4 years (2017-2020) under two scenarios: scenario 1, assuming NAC reconstruction was performed in one breast (unilateral) in 80 % of patients, and in both (bilateral) in 20 % of patients; scenario 2: assuming NAC reconstruction was for performed for one breast (unilateral) in all patients. • To explore the opinions of women concerning the process of NAC micropigmentation, we carried out a qualitative study (using focus groups) with members of Basque associations for women who have or have had breast cancer asking them to define how they would like this technique to be integrated into the services provided by the Spanish National Health System and describe their views of micropigmentation as the final phase of breast reconstruction. • To determine the criteria necessary under the current Spanish legislation to ensure that micropigmentation is carried out by professionals with appropriate skills, protecting patient safety, we performed a non-structured search of the websites of the Spanish Micropigmentation Association (AEM), the Association for Aesthetic, Paramedical and Oncological Micropigmentation (AMEPO) and the Spanish Agency of Medicines and Medical Devices (AEMPS).

Project Status: Completed

Year Published: 2018

URL for published report: https://www.euskadi.eus/web01-a2aznscp/es/k75aWebPublicacionesWar/k75aObtenerPublicacionDigitalServlet?R01HNoPortal=true&N_LIBR=052131&N_EDIC=0001&C_IDIOM=es&FORMATO=.pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government</p>